Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery

Pain, Procedural Clinical Trial

Official title:

Comparison of Three Different Analgesic Nerve Blocks in Total Knee Replacement Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422585
• Other study ID #: PGBLOCK
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Serena Ricalzone, MD
• Phone: 050.997881
• Email: serenaricalzone[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is:

• Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in.

Researchers will compare the Femoral Nerve Group+IPACK block, the Saphenous Nerve block+IPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery.

Description:

After adequate venous access is obtained, a light sedation with Midazolam 1-2 mg is administered. The patient will be monitored and a selective spinal anesthesia will be performed. After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic.

Magnesium Solfate 1g and Dexametasone 4mg are administered after the block. If the patient wishes, a propofol continuos infusion may be administered for sedation during the surgery. Before the patient leaves the OR, Ketorolac 30mg will be administered.

Pain control after surgery will be achieved with acetaminophen 1g t.i.d., Ketorolac 30mg on demand, and Morphine solfate if NRS >5 after Ketorolac.

Every 6 hours the patient will be monitored by the anesthesia team. After 24 hours the antalgic effect of the nerve block is reasonably thought to be over, so the follow up is interrupted.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 y/o

• Total knee replacement elective surgery

• Informed consent

Exclusion Criteria:

• Age < 18 y/o

• Surgery with general anesthesia

• Patients with coagulopaties

• Patients in chronic opioid therapy

• Refuse to sign informed consent form

• Unable to sign informed consent form

• Know allergies to medication used for analgesia

Related Conditions & MeSH terms

• Knee Prosthesis
• Pain, Procedural

Locations

Country	Name	City	State
Italy	Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello	Pisa	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS	To compare the analgesic effect at 24 hours, of a nerve block technique compared to others after selective spinal anesthetic is administerd to achieve surgical anesthesia.Evaluate pain for every group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three.; Success of the block was defined as NRS=3.	Baseline, every 6 hours for the first 24 hours after surgery
Secondary	side effect	Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours	24 hours